Samsung Files Remicade Biosimilar In Europe

Following an approval filing for its Enbrel biosimilar candidate in the EU earlier this year, Samsung is now expanding its European biosimilar ambitions to Remicade.

SEOUL – South Korea’s Samsung Bioepis Co. Ltd. is gearing up to raid burgeoning biosimilar territory, this time by submitting a Marketing Authorization Application (MAA) to the European Medicines Agency for SB2, its Remicade (infliximab) biosimilar candidate.

In January, the firm announced that its biosimilar version of Amgen Inc.’s arthritis blockbuster Enbrel (etanercept) had been validated and accepted for review by the EMA, marking the first biosimilar of the drug to advance into regulatory review in the European Union.

This month, Samsung then applied for biosimilar Enbrel approval from South Korea’s Ministry of Food and Drug Safety (MFDS; formerly the Korea FDA), hoping that both the EMA and MFDS approval will come around the same time early next year (Also see "Samsung Bioepis Files Biosimilar Enbrel In South Korea" - Scrip, 16 Mar, 2015.).

"If this MAA [for SB2] is approved by EMA, Samsung Bioepis will provide rheumatoid arthritis patients in Europe with an important new treatment option," said Christopher Hansung Ko, chief executive officer of the company, noting that the biosimilar will be commercialized in Europe by strategic partner Biogen Inc.

Samsung Bioepis is itself a joint venture with the US firm, under which Samsung is aiming to take advantage of its partner’s expertise in protein engineering, biologics manufacturing and commercialization. Samsung Bioepis's sister company Samsung BioLogics plays the role of a contract manufacturing organization (Also see "Samsung and Biogen Idec Launch Biosimilar Joint Venture" - Scrip, 28 Feb, 2012.).

The EU filing for Samsung Bioepis’s second biosimilar candidate is based on results from an extensive head-to-head preclinical data package comparing SB2 to the originator, a comparative Phase I study in healthy volunteers, and also a robust head-to-head Phase III equivalence trial in patients with moderate-to-severe rheumatoid arthritis (RA).

In Europe, Samsung noted Remicade is indicated for the treatment of rheumatoid arthritis, adult Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis, ankylosing spondylitis and psoriasis. If authorized by the EMA, SB2 could be available for all of the same indications as Remicade.

"Except Europe, Samsung should achieve approvals from each country to sell the biosimilar," Samsung told PharmAsia News. "Samsung will apply to Korea’s MFDS for the approval of SB2 pretty soon."

South Korea’s Celltrion Inc. is already selling its Remicade biosimilar in Europe through partners in each country while its strategic partner Hospira Inc. is marketing the product under a different brand name. Celltrion is pushing now to sell the product in more countries in Europe (Also see "Celltrion To Launch Biosimilar Remicade in More European Countries" - Scrip, 9 Feb, 2015.).

Remicade, for which Johnson & Johnson had patent protection in most of Western Europe until February 2015, generated $6.67 billion in global sales in 2013, up from $6.14 billion in 2012. In Europe in 2012, sales of Remicade, used mainly in rheumatoid arthritis, exceeded $2 billion (Also see "Korea’s Celltrion, Partner Hospira Win Drug Procurement Bid In Norway For Infliximab Biosimilar" - Scrip, 29 Jan, 2014.).

Samsung’s Pipeline Biosimilars

Five biosimilars are currently in Samsung’s pipeline, including those of Enbrel and Remicade. The others are Roche's Herceptin (trastuzumab), AbbVie Inc.’s Humira (adalimumab) and Sanofi’s Lantus (insulin glargine), and are now under international Phase III trials in Asia, Europe and the U.S., Samsung said.

If SB2 is approved by the MFDS in South Korea, it would be the fifth South Korean company-produced biosimilar approved in the country.

Remsima, Celltrion’s biosimilar version of Remicade, was the first biosimilar to be approved locally, followed by Celltrion's Herzuma, a version of Roche’s blockbuster Herceptin. In November 2014, Hanwha Chemical Corp. - which is trying to pull out from biosimilars except for Enbrel - won MFDS approval for its Enbrel biosimilar

Because of the harsh business environment in South Korea, beginning with the April 2012 drastic drug price cuts and tightened surveillance on rebates and business irregularities, South Korean pharma firms are stepping up efforts to enter global markets with competitive products such as biosimilars (Also see "Korea 2014 Outlook: Not Much Positive News On Pharma" - Scrip, 16 Jan, 2014.).

Hanmi Pharmaceutical Co. Ltd. is also seeking opportunities and in early 2012 signed an agreement with Spectrum Pharmaceuticals Inc. to co-develop and commercialize Hanmi’s biobetter SPI-2012, formerly known as LAPS-GCSF, for neutropenia.

The product is a version of Amgen‘s granulocyte colony-stimulating factor Neulasta (pegfilgrastim) (Also see "Korea’s Hanmi, U.S. Spectrum To Co-Develop Biobetter Of Amgen’s GCSF Neulasta For Neutropenia" - Scrip, 3 Feb, 2012.).